Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model# 882310,882311,882313 All Lots
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Philips North America, LLC
- Reason for Recall:
- A software defect that has the potential to result in image misdiagnosis and incorrect treatment of a patient.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Emission Computed Tomography System Image Process System - Product Usage: intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body.
Product Codes/Lot Numbers:
Model# 882310,882311,882313 All Lots
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0852-2021
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